Place of work: Priemyselný park 3, Michalovce, Slovakia. Occasional travelling abroad to support validation activities within further CVT plants (based upon pre-agreement).

Wage (gross) and other rewards:  minimum 1450€ / monthly (depending on experiences and quality of the candidate) + quarterly bonus and other benefits in compliance with social benefit program of the company.

Contract type: full-time.

Start date: by agreement. 

About the role: 

Position is supposed to cover validation of manufacturing  processes in manufacturing units to be performed on time and in compliance with standards. This is one of the key positions for realizing the first production and products of good quality and to the specification within defined frame of set ups.

The role belongs to a new global group which is being developed at the moment and poses a chance and opportunity to work within the international team in our plants all around the globe with occasional traveling or to be local based only – according your preferences. Huge potential for your growth and development.

Your key duties and responsibilities as a  Engineer - Validation:

This role is a local role, and the holder of this position is responsible for:

• Validation of new or existing production processes within CVT business units (Continence care, Ostomy care, Advanced wound care, Infusion devices). The processes can involve but not limited to packaging, welding process, extrusion and catheter assembly process. Validation consists of compilation of testing based upon the protocol (plan) and report, where the testing results are recorded and assessed. All documentation is written by filling in into the existing predefined templates so that is no need to create new ones.

• Validation documentation preparations used common Microsoft office software’s (MS office), submission and their electronic archiving in validated environment (simple upload in the documentation electronic system). The documentation may include but not limited to Validation plan and Validation Summary report and protocol and reports for the phases applied during the validation process.

• Cooperation with all other departments which help and participate within the validation work (operators, technician, quality) to ensure smooth validation process in order to be aligned with predefined time plan and regulations.

• Re-validation of the processes as per time plan. Revalidation is done by a team assessment of the gathered information. Your role will be recapping the results and issue a simple report.

• Preferred – if the software is your hobby, we offer your development in software validation with a huge potential for the future as our processes are digitalized and robotized.

• You will be leading the validation activity within a small team which need to be trained by you on what needs to be done (which tests, adjustments etc.).

• Update and maintain validation database so that all validation documentation references are recorded and easily accessible and the database is maintained to be up to date (update means that the references of your validation documentation is filled out into the excel spreadsheet).

• Updating and creating machine cards. Machine card is a document which is created using MS Word and contains the process parameters (temperature, pressure, time, etc.) which are necessary for machine set up.  

• You will be participating (supporting) in a troubleshooting to present your view based upon your expertise and opinion.

• You will use statistical techniques to evaluate the testing results. There are few basic statistical techniques which you get a full training and support in their usage.

• Providing regular updates to relevant manager in order to support you in the role and understand your needs and suggestions.

About you: 

Required:

• At least 2 years of relevant work experience as process or technology engineer.

• Knowledge and experience in operations, manufacturing engineering especially in medical devices industry is a big advantage.

Preferred:

• Experience in process or other validation (measuring equipment, design, software) and capability.

• Minitab software, statistical techniques knowledge, GMP.

• Previously held roles as a process or quality engineers having skills on process mappings, risk management, root cause investigation, measuring system analysis.

• Must be proficient with PC programs i.e. Office (Excel and Word).

• Software understanding (in general).

Education / Qualifications: 

• Masters or advanced degree preferred in Technical/ Engineering or Quality Management.

• Root cause analyze tools – advantage.